Actively Recruiting
A Phase I, Open-label, Dose Finding Study of NILK-2301, a Bispecific CEACAM5 X CD3 Engaging Antibody, in Patients with Locally Advanced or Metastatic Low Tumor Volume Colorectal Cancer
Led by Light Chain Bioscience - Novimmune SA · Updated on 2024-10-29
25
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying NILK-2301, a bispecific antibody, in patients with locally advanced or metastatic low tumor volume colorectal cancer. This open-label, Phase 1 clinical trial aims to find the safest dose and evaluate the effects of NILK-2301 administered alone. The study includes two parts: dose escalation to determine the maximum tolerated dose and expansion to assess safety and efficacy at or below this dose. Participants will receive NILK-2301 treatments every two weeks in 28-day cycles for up to 12 months. Treatment may continue beyond one year if ongoing benefit is observed. The study will monitor patients during dose escalation and expansion phases to assess safety, tolerability, and response. During the trial, participants will undergo regular safety assessments including monitoring for dose limiting toxicities, adverse events, and laboratory tests. Researchers will also evaluate progression-free survival, overall survival, drug levels in the body, and the presence of anti-drug antibodies. Participation can last up to 12 months, with treatment continuing until disease progression, unacceptable side effects, or withdrawal by participant or investigator.
CONDITIONS
Brief Title
A Study of NILK-2301 in Patients with Locally Advanced or Metastatic Low Tumor Volume (LTV) Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older at the time of consent
- Confirmed diagnosis of colorectal cancer by histology or cytology
- Locally advanced or metastatic disease after at least one prior systemic treatment
- Failed, intolerant to, or not candidates for available therapies that provide clinical benefit
- Measurable disease per RECIST version 1.1 guidelines
- Tumor lesions total volume up to approximately 50 cc and longest diameter of measurable lesions less than 7 cm
- Any measurable lesion longest diameter 5 cm or less
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Specific laboratory values including ANC ≥ 1.0 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 10 g/dL, normal or correctable potassium, AST/ALT ≤ 2.5 x ULN, ALP ≤ 3 x ULN, bilirubin < 1.5 x ULN, glomerular filtration rate ≥ 45 mL/min/1.73 m2, INR < 1.5 x ULN, and PTT < 1.5 x ULN
- Females of childbearing potential must have negative pregnancy tests and agree to use effective birth control during and 28 days after treatment
You will not qualify if you...
- Known allergy or hypersensitivity to NILK-2301 or its components
- Presence of central nervous system lesions or bone disease
- Pleural or pericardial tumor lesions
- Radiotherapy to target lesions within 4 weeks before the first dose
- Anti-cancer therapy including chemotherapy, hormonal therapy, or investigational agents within 28 days prior to dosing (with some exceptions)
- Participation in other investigational therapies during the study
- Severe cardiac dysfunction (NYHA III-IV)
- Significant liver dysfunction (bilirubin ≥ 1.8 mg/dL or AST/ALT ≥ 2.5 x ULN)
- Known HIV infection or history of hepatitis B or C
- Uncontrolled active infections or intravenous anti-infective treatment within 2 weeks prior to dosing
- Autoimmune diseases or conditions requiring permanent immunosuppression (low-dose steroids allowed in some cases)
- Active malignancy requiring systemic treatment
- CNS metastases, leptomeningeal disease, or seizure disorder requiring therapy
- ANC less than 1 x 10^9/L
- Pregnancy or breastfeeding
- Psychiatric illness or substance abuse interfering with study compliance
- Significant medical conditions increasing risk, including recent heart attack or major surgery
- Unresolved acute toxic effects from prior therapies except specified conditions
- Live or live attenuated vaccine exposure within 28 days prior to consent
- Previous treatment with CEACAM5 targeting agents or T-cell bispecific antibodies or CAR T-cells
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive the study drug NILK-2301 administered every two weeks in 28-day cycles for up to 12 months until disease progression, unacceptable toxicity, or decision to withdraw.
Biweekly visits every 2 weeks
Trial Site Locations
Total: 2 locations
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Actively Recruiting
2
START Madrid-FJD, Hospital Fundación Jiménez Díaz
Madrid, Spain
Actively Recruiting
Research Team
C
Clinical Project Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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